ZS Ph2/3 Dose-response Study in Japan

Brief description of study

Detailed Study Description

Patients not receiving any therapy for hyperkalemia and with 2 consecutive i-STAT potassium
values of ≥ 5.1 mmol/L and ≤ 6.5 mmol/L will be enrolled and randomized 1:1:1 to receive ZS 5
g, ZS 10 g, or placebo TID for 48 hours.
Throughout the study most potassium values will be measured at fasting before taking study
drug. Nothing should be taken by mouth except water, coffee or tea, with or without milk
and/or sugar, and essential medications, prior to the blood collection for a minimum of 8
hours. Potassium level should be determined by both i-STAT and the Central Laboratory on all
occasions. Treatment decisions (eg, stopping rules) will be made based on i-STAT potassium
values, as these provide clinical sites with a real-time measurement. Statistical analyses on
the study data will in principle be based on S-K values as measured by the central
laboratory.
Safety and tolerability will be assessed on an ongoing basis. Standard study assessments
including blood potassium, clinical chemistry (including calcium, magnesium, sodium,
phosphate, creatinine, bicarbonate, and blood urea nitrogen [BUN]) and hematology parameters,
urinalysis, vital signs, physical examinations, and electrocardiograms (ECGs) will be
assessed during the study at the time points specified in the assessments schedule. All women
of childbearing potential will have a urine pregnancy test prior to enrollment and at their
End of Study (EOS) visit.
Stopping rules will be implemented to ensure subjects discontinue the study treatment and
receive alternative therapy in case of significant hyperkalemia, hypokalemia, or significant
cardiac arrhythmias.